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IMIPENEM/CILASTATIN 250/250MG POWDER FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Imipenem/Cilastatin 250 mg/250 mg
Powder for Solution for Infusion
Imipenem/Cilastatin 500 mg/500 mg
Powder for Solution for Infusion

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Imipenem/Cilastatin may be used to treat bacterial infection of the blood which might be
associated with a type of infection mentioned above.

2

imipenem/cilastatin

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Imipenem/Cilastatin is and what it is used for
2. What you need to know before you use Imipenem/Cilastatin
3. How to use Imipenem/Cilastatin
4. Possible side effects
5. How to store Imipenem/Cilastatin
6. Contents of the pack and other information

1

What you need to know before you use Imipenem/Cilastatin

Do not use Imipenem/Cilastatin
• if you are allergic to imipenem, cilastatin or any of the other ingredients of this medicine
(listed in section 6)
• if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems

Warnings and precautions
Tell your doctor about any medical condition you have or have had including:
• allergies to any medicines including antibiotics (sudden life-threatening allergic reactions
require immediate medical treatment)
• colitis or any other gastrointestinal disease
• any central nervous system disorders such as localized tremors or epileptic seizures
• liver, kidney or urinary problems

You may develop a positive test (Coombs test) which indicates the presence of antibodies that
may destroy red blood cells. Your doctor will discuss this with you.

Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Other
medicines and Imipenem/Cilastatin below).

Children
Imipenem/Cilastatin is not recommended in children less than one year of age or children with
kidney problems.

What Imipenem/Cilastatin is and what it is used for

Imipenem/Cilastatin belongs to a group of medicines called carbapenem antibiotics. It kills a
wide range of bacteria (germs) that cause infections in various parts of the body in adults and
children one year of age and above.
Treatment

Your doctor has prescribed Imipenem/Cilastatin because you have one (or more) of the
following types of infection:
• Complicated infections in the abdomen
• Infection affecting the lungs (pneumonia)
• Infections that you can catch during or after the delivery
• Complicated urinary tract infections
• Complicated skin and soft tissue infections

The following information is intended for healthcare professionals only:

Imipenem/Cilastatin may be used in the management of patients with low white blood cell
counts, who have fever that is suspected to be due to a bacterial infection.

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This is an extract from the Summary of Product Characteristics (SmPC) to assist in the
administration of Imipenem/Cilastatin. When determining appropriateness of use in a
particular patient, the prescriber should be familiar with the SmPC.

Posology
The dose recommendations for Imipenem/Cilastatin represent the quantity of
imipenem/cilastatin to be administered.

The daily dose of Imipenem/Cilastatin should be based on the type and severity of infection, the
pathogen(s) isolated, the patient's renal function and body weight (see also section 4.4 and 5.1).
Adults and adolescents
For patients with normal renal function (creatinine clearance of > 70 ml/min/1.73 m2), the
recommended dose regimens are:
500 mg/500 mg every 6 hours OR
1000 mg/1000 mg every 8 hours OR every 6 hours

It is recommended that infections suspected or proven to be due to less susceptible bacterial
species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic
patients with a fever) should be treated with 1000 mg/1000 mg administered every 6 hours.
A reduction in dose is necessary when:
• creatinine clearance is ≤ 70 ml/min/l.73 m2 (see Table 1) or
• body weight is < 70 kg. The proportionate dose for patients < 70 kg would be calculated
using the following formula:

Other medicines and Imipenem/Cilastatin
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including those obtained without a prescription.

Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.

Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy,
bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
Your doctor will decide whether you should use Imipenem/Cilastatin in combination with these
medicines.

Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking this medicine. Imipenem/Cilastatin has not been
studied in pregnant women. Imipenem/Cilastatin should not be used during pregnancy unless
your doctor decides the potential benefit justifies the potential risk to the foetus.

Actual body weight (kg) X standard dose
70 (kg)
The maximum total daily dose should not exceed 4000 mg/4000 mg per day.

2.

The total daily dose (i.e. 2000/2000, 3000/3000 or 4000/4000 mg) that would usually be
applicable to patients with normal renal function should be selected.
From table 1 the appropriate reduced dose regimen is selected according to the patient's
creatinine clearance. For infusion times see Method of administration.

Table 1: Reduced dose in adults with impaired renal function and body weight ≥ 70 kg*
Total daily dose for
patients with normal
renal function
(mg/day)

41-70

Creatinine clearance (ml/min/1.73 m2)

2000/2000

500/500 (8)

4000/4000

21-40

dose in mg (interval hrs)

750/750 (8)

3000/3000

250/250 (6)

500/500 (6)

500/500 (8)

6-20

250/250 (12)

500/500 (12)**

500/500 (6)

500/500 (12)**

* A further proportionate reduction in dose administered must be made for patients with a body
weight < 70 kg. The proportionate dose for patients < 70 kg would be calculated by dividing the

Artwork Proof Box
Ref: V001: CDS update for SPC, PIL & Labels, RFI
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Date prepared:
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Driving and using machines
There are some side effects associated with this product (such as seeing, hearing, or feeling
something that is not there, dizziness, sleepiness, and a spinning sensation) that may affect
some patients' ability to drive or operate machinery (see section 4).

Imipenem/Cilastatin contains Sodium hydrogen carbonate
Imipenem/Cilastatin 250 mg/250 mg: This medicinal product contains approximately 0.82 mmol
(approximately 18.7 mg) of sodium per 250 mg dose which should be taken into consideration
by patients on a controlled sodium diet.

Imipenem/Cilastatin 500 mg/500 mg: This medicinal product contains approximately 1.63 mmol
(approximately 37.6 mg) of sodium per 500 mg dose which should be taken into consideration
by patients on a controlled sodium diet.

3

How to use Imipenem/Cilastatin

Imipenem/Cilastatin will be prepared and given to you by a doctor or another health care
professional. Your doctor will decide how much Imipenem/Cilastatin you need.

Adults and adolescents
The usual dose of Imipenem/Cilastatin for adults and adolescents is 500 mg/500 mg every 6
hours or 1,000 mg/1,000 mg every 6 or 8 hours. If you have kidney problems or weigh less
than 70 kg, your doctor may lower your dose.

Children
The usual dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6
hours. Imipenem/Cilastatin is not recommended in children under one year of age and children
with kidney problems.
Method of administration
Imipenem/Cilastatin is given intravenously (into a vein) over 20-30 minutes for a dose of ≤
500 mg/500 mg or 40-60 minutes for a does of > 500 mg/500 mg.

If you use more Imipenem/Cilastatin than you should
Symptoms of overdose may include seizures, confusion, tremors, nausea, vomiting, low blood
pressure and slow heart rate. If you are concerned that you may have been given too much
Imipenem/Cilastatin, contact your doctor or another healthcare professional immediately.

Continued on the next page >>

patient's actual body weight (in kg) by 70 kg multiplied by the respective dose recommended in
Table 1.
** When the 500 mg/500 mg dose is used in patients with creatinine clearances of 6 to
20 ml/min/l.73 m2, there may be an increased risk of seizures.

Renal impairment
To determine the reduced dose for adults with impaired renal function:

1.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed
before receiving Imipenem/Cilastatin. Small amounts of this medicine may pass into breast
milk and it may affect the baby. Therefore, your doctor will decide whether you should use
Imipenem/Cilastatin while breast-feeding.

Patients with a creatinine clearance of ≤ 5 ml/min/1.73 m2
These patients should not receive Imipenem/Cilastatin unless haemodialysis is instituted within
48 hours.
Patients on haemodialysis
When treating patients with creatinine clearances of ≤ 5 ml/min/1.73 m2 who are undergoing
dialysis use the dose recommendation for patients with creatinine clearances of 6 to
20 ml/min/1.73 m2 (see table 1).

Both imipenem and cilastatin are cleared from the circulation during haemodialysis. The patient
should receive Imipenem/Cilastatin after haemodialysis and at 12 hour intervals timed from the
end of that haemodialysis session. Dialysis patients, especially those with background central
nervous system (CNS) disease, should be carefully monitored; for patients on haemodialysis,
Imipenem/Cilastatin is recommended only when the benefit outweighs the potential risk of
seizures (see section 4.4).
Currently there are inadequate data to recommend use of Imipenem/Cilastatin for patients on
peritoneal dialysis.

Continued on the next page >>

If you forget to use Imipenem/Cilastatin
If you are concerned that you may have missed a dose, contact your doctor or another
healthcare professional immediately.

Do not take a double dose to make up for a forgotten dose.

If you stop using Imipenem/Cilastatin
Do not stop using Imipenem/Cilastatin until your doctor tells you to.

4

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
• Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in
patients with low number of white blood cells
• Swelling and redness along a vein which is extremely tender when touched
• Rash
• Abnormal liver function detected by blood tests
• Increase in some white blood cells

Uncommon: may affect up to 1 in 100 people
• Local skin redness
• Local pain and formation of a firm lump at the injection site
• Skin itchiness
• Hives
• Fever
• Blood disorders affecting the cell components of the blood and usually detected by blood
tests (symptoms may be tiredness, paleness of skin, and prolonged bruising after injury)
• Abnormal kidney, liver and blood function detected by blood tests
• Tremors and uncontrolled twitching of muscles
• Seizures
• Psychic disturbances (such as mood swings and impaired judgment)
• Seeing, hearing or feeling something that is not there (hallucinations)
• Confusion
• Dizziness, sleepiness
• Low blood pressure

Rare: may affect up to 1 in 1,000 people
• Allergic reactions including rash, swelling of the face, lips, tongue and/or throat (with
difficulty in breathing or swallowing), and/or low blood pressure. If these side-effects occur
while receiving or after receiving Imipenem/Cilastatin, the medicine must be stopped
and your doctor contacted immediately.
• Skin peeling (toxic epidermal necrolysis)
• Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
• Severe skin rash with loss of skin and hair (exfoliative dermatitis)

Hepatic impairment
No dose adjustment is recommended in patients with impaired hepatic function (see section
5.2).

Elderly population
No dose adjustment is required for the elderly patients with normal renal function (see section
5.2).
Paediatric population ≥ 1 year of age
For paediatric patients ≥ 1 year of age, the recommended dose is 15/15 or 25/25 mg/kg/dose
administered every 6 hours.

It is recommended that infections suspected or proven to be due to less susceptible bacterial
species (such as Pseudomonas aeruginosa) and very severe infections (e.g. in neutropenic
patients with a fever) should be treated with 25/25 mg/kg administered every 6 hours.
Paediatric population < 1 year of age
Clinical data are insufficient to recommend dosing for children less than 1 year of age

Paediatric population with renal impairment
Clinical data are insufficient to recommend dosing for paediatric patients with renal impairment
(serum creatinine > 2 mg/dl). See section 4.4.
Preparation of intravenous solution
The following table is provided for convenience in reconstituting Imipenem/Cilastatin for
intravenous infusion.












leaflet ʻThe following information is intended for medical or healthcare professionals onlyʼ.

Fungal infection (candidiasis)
Staining of the teeth and/or tongue
Inflammation of the colon with severe diarrhoea
Disturbances in taste
Inability of the liver to perform normal function
Inflammation of the liver
Inability of the kidney to perform normal function
Changes in the amount of urine, changes in urine colour
Disease of the brain, tingling sensation (pins and needles), localised tremor
Hearing loss

Your doctor or pharmacist will know how to store Imipenem/Cilastatin. Do not throw away any
medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

Very rare: may affect up to 1 in 10,000 people
• Severe loss of liver function due to inflammation (fulminant hepatitis)
• Inflammation of stomach or intestine (gastro-enteritis)
• Inflammation of intestine with bloody diarrhoea (haemorrhagic colitis)
• Red swollen tongue, overgrowth of the normal projections on the tongue giving it a hairy
appearance, heartburn, sore throat, increase in the production of saliva
• Stomach pain
• A spinning sensation (vertigo), headache
• Ringing in the ears (tinnitus)
• Pain in several joints, weakness
• Irregular heartbeat, the heart beating forcefully or rapidly
• Chest discomfort, difficulty breathing, abnormally fast and superficial breathing, pain in the
upper spine
• Flushing, bluish discoloration of the face and lips, skin texture changes, excessive sweating
• Itching of the vulva in women
• Changes in the amounts of blood cells
• Worsening of a rare disease associated with muscle weakness (aggravation of myasthenia
gravis)

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information
on the safety of this medicine.

5

How to store Imipenem/Cilastatin

6

Contents of the pack and other information

What Imipenem/Cilastatin contains
The active substances are:
Imipenem/Cilastatin 250 mg/250 mg Powder for Solution for Infusion
Imipenem monohydrate equivalent to 250 mg anhydrous Imipenem
Cilastatin sodium equivalent to 250 mg Cilastatin

Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion
Imipenem monohydrate equivalent to 500 mg anhydrous Imipenem
Cilastatin sodium equivalent to 500 mg Cilastatin
The other ingredient is:
Sodium hydrogen carbonate

What Imipenem/Cilastatin looks like and contents of the pack
Powder for solution for infusion.

Imipenem/Cilastatin 250 mg/250 mg Powder for Solution for Infusion is available as Type I
(20 ml) clear glass vials containing sterile white to light yellow powder.

Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion is available as Type I
(20 ml or 100 ml) clear glass vials containing sterile white to light yellow powder
Pack sizes: 1, 5, 10, 20 and 25 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.
The expiry date refers to the last day of that month.

This leaflet was last revised in 12/2013.

Vials of dry Imipenem/Cilastatin should be stored below 25°C. The container should be kept in
the outer carton until immediately before use in order to protect from light. The reconstituted
medicinal product should be used immediately.
For storage conditions of the reconstituted medicinal product, see at the end of the package

Strength

Imipenem/Cilastatin
250 mg/250 mg
Imipenem/Cilastatin
500 mg/500 mg

Volume of solvent added (ml)

Approximate concentration of
imipenem (mg/ml)

100

5

50

5

Reconstitution of 20 ml vial
Contents of the vials must be dissolved and transferred to 50 ml (for 250 mg strength) or
100 ml (for 500 mg strength) of an appropriate infusion solution. A suggested procedure is to
add approximately 10 mL from the appropriate infusion solution (see 'Compatibility and
Stability')) to the vial. Shake well and transfer the resulting suspension to the infusion solution
container.

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Compatibility and stability
In keeping with good clinical and pharmaceutical practice, Imipenem/Cilastatin 250 mg/250 mg
Powder for Solution for Infusion and Imipenem/Cilastatin 500 mg/500 mg Powder for Solution
for Infusion should be administered as a freshly prepared solution in any of the following
diluents.
Diluents

0.9% Sodium Chloride
Injection

Concentration [mg/ml]
5

Use Periods/
Storage Conditions

The reconstituted product
should be used immediately

CAUTION: THE SUSPENSION IS NOT FOR DIRECT INFUSION.

Repeat with an additional 10 mL of infusion solution to ensure complete transfer of vial
contents to the infusion solution. The resulting mixture should be agitated until clear.

Reconstitution of 100 ml vial
Contents of the vials must be reconstituted with 100 ml of an appropriate infusion solution.

The reconstituted solution should be inspected visually for particulate matter and discolouration
prior to administration. Any unused solution and the vial should be adequately disposed of, in
accordance with local requirements.

Artwork Proof Box
Ref: V001: CDS update for SPC, PIL & Labels, RFI
Proof no.
002.1

Date prepared:
16/12/2013

Colours:
Black
Dimensions: 340 x 260 mm

Font size:
7pt
Fonts:
Helvetica

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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